Sleep Apnea is a common disorder affecting approximately 20,000,000 Americans. Sleep Apnea refers to a cessation of breathing during sleep that lasts at least 10 seconds. Snoring is another common sleep disorder. By conservative estimates, approximately 80,000,000 Americans are afflicted with snoring.
These sleep disorders cause countless hours of lost sleep and productivity for the afflicted persons, as well as their sleeping partners. In addition, Sleep Apnea is highly associated (50%) with essential hypertension, obesity and heart disease. Moreover, extreme cases of Sleep Apnea can be life threatening.
Current therapy includes sleep position modification, weight loss, and/or lifestyle changes such as the elimination of alcohol, drug use and/or over-eating. Other therapies include the use of mechanical devices such as oral or nasal devices that augment the airway, surgical procedures to enlarge and stabilize the airway during sleep, and continuous positive airway pressure devices.
Nasal devices that dilate the anterior nares by external traction or internal splinting have been used with minimal success. Nasal intubation is poorly tolerated and traumatic to the user.
Current oral devices are typically of two types. One type of oral device involves a tongue retention device that advances and secures the tongue using suction, or mechanical tongue depression and stabilization. However, this type of oral device has limited success and is poorly tolerated by the user. A second type of oral device is a mandibular repositioning device that advances the lower jaw relative to the fixed upper jaw to expand the cross-sectional area of the pharynx thereby improving airflow and preventing collapse. These devices have been variably effective, but commonly have both comfort and compliance problems.
Surgical treatments are varied and include reconstruction of the palate and uvula, various methods to shrink and stiffen the soft tissue of the upper airway, tonsillectomy, laser treatment, radio frequency tissue reduction, hyoid suspension, and tongue base excision and retention. More radical surgical treatments for severe disorders include tracheotomy and surgical advancement of the upper and lower jaws. Surgical treatments are typically highly expensive, painful, complicated and have varying success rates (typically 40-60%).
Nasal and/or oral continuous positive airway pressure has been the most successful of the current sleep disorder treatments. However, this treatment is highly expensive and poorly tolerated by many user's who typically find the treatment intrusive and intolerable. Accordingly, a need exists for an effective, well tolerated, economical treatment for persons afflicted with sleep disordered breathing.
There are approximately 31,000,000 outpatient surgeries and 40,000,000 inpatient surgical procedures performed annually in the United States. These procedures usually involve some form of anesthesia and sedation, which inherently requires airway management of the sedated patient. The airway is typically managed by an administrator such as the treating physician (M.D. or D.D.S.), an Anesthesiologist M.D. or a Certified Registered Nurse Anesthetist, among other appropriate administrators. The type of airway required for any given procedure is determined by safety considerations. In general, more deeply sedated and anesthetized patients require a more secure airway. The most secure airways involve endotracheal intubation with an airtight watertight seal within the tracheal lumen. Some procedures do not require a completely secure airway as patients may retain some of their protective reflexes in lighter stages of sedation. Alternative airways may be selected under these circumstances at the discretion of the administrator. Each airway type has intrinsic risks and the decision to use any particular airway is typically made by an analysis of the risk-benefit ratio for each individual patient. Accordingly, a need exists for an airway to facilitate the breathing of a sedated patient.